Nilemdo Special Precautions

Hyperuricemia: Nilemdo inhibits renal tubular OAT2 and may increase blood uric acid levels [see Pharmacology: Pharmacokinetics under Actions]. In clinical trials, 26% of Nilemdo-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment. After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid compared to baseline was 0.8 mg/dL for patients treated with Nilemdo.
Elevated blood uric acid may lead to the development of gout. Gout was reported in 1.5% of patients treated with Nilemdo and 0.4% of patients treated with placebo. The risk for gout events was higher in patients with a prior history of gout (11.2% Nilemdo versus 1.7% placebo), although gout also occurred more frequently than placebo in patients treated with Nilemdo who had no prior gout history (1.0% Nilemdo versus 0.3% placebo).
Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Nilemdo is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Nilemdo versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting Nilemdo. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Discontinue Nilemdo immediately if the patient experiences rupture of a tendon. Consider discontinuing Nilemdo if the patient experiences joint pain, swelling, or inflammation.
Advise patients to rest at the first sign of tendinitis or tendon rupture and to contact their healthcare provider if tendinitis or tendon rupture symptoms occur. Consider alternative therapy in patients with a history of tendon disorders or tendon rupture.
Renal Impairment: No dosage adjustment is necessary in patients with mild or moderate renal impairment. There is limited experience with Nilemdo in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²), and Nilemdo has not been studied in patients with end-stage renal disease (ESRD) receiving dialysis [see Pharmacology: Pharmacokinetics under Actions].
Hepatic Impairment: No dosage adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B) [see Pharmacology: Pharmacokinetics under Actions]. Patients with severe hepatic impairment (Child-Pugh C) have not been studied.
Use in Children: The safety and effectiveness of Nilemdo have not been established in pediatric patients.
Use in the Elderly: Of the 3009 patients in clinical trials of Nilemdo, 1753 (58%) were 65 years and older, while 478 (16%) were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.